Surgical approach to hysterectomy for benign gynaecological disease

Cochrane Systematic Review - Intervention Version published: 12 August 2015

Johanna WM Aarts

 Theodoor E Nieboer
 Neil Johnson
 Emma Tavender
 Ray Garry
 Ben Willem J Mol
 Kirsten B Kluivers

Background

The four approaches to hysterectomy for benign disease are abdominal hysterectomy (AH),
vaginal hysterectomy (VH), laparoscopic hysterectomy (LH) and robotic‐assisted
hysterectomy (RH).

Objectives

To assess the effectiveness and safety of different surgical approaches to hysterectomy for
women with benign gynaecological conditions.

Search methods

We searched the following databases (from inception to 14 August 2014) using the Ovid
platform: Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE;
EMBASE; Cumulative Index to Nursing and Allied Health Literature (CINAHL) and
PsycINFO. We also searched relevant citation lists. We used both indexed and free‐text
terms.

Selection criteria

We included randomised controlled trials (RCTs) in which clinical outcomes were compared
between one surgical approach to hysterectomy and another.

Data collection and analysis

At least two review authors independently selected trials, assessed risk of bias and performed
data extraction. Our primary outcomes were return to normal activities, satisfaction, quality
of life, intraoperative visceral injury and major long‐term complications (i.e. fistula, pelvi‐
abdominal pain, urinary dysfunction, bowel dysfunction, pelvic floor condition and sexual
dysfunction).

Main results

We included 47 studies with 5102 women. The evidence for most comparisons was of low or
moderate quality. The main limitations were poor reporting and imprecision.
Vaginal hysterectomy (VH) versus abdominal hysterectomy (AH) (nine RCTs, 762
women)
Return to normal activities was shorter in the VH group (mean difference (MD) ‐9.5 days,
95% confidence interval (CI) ‐12.6 to ‐6.4, three RCTs, 176 women, I2 = 75%, moderate
quality evidence). There was no evidence of a difference between the groups for the other
primary outcomes.
Laparoscopic hysterectomy (LH) versus AH (25 RCTs, 2983 women)
Return to normal activities was shorter in the LH group (MD ‐13.6 days, 95% CI ‐15.4 to ‐
11.8; six RCTs, 520 women, I2 = 71%, low quality evidence), but there were more urinary
tract injuries in the LH group (odds ratio (OR) 2.4, 95% CI 1.2 to 4.8, 13 RCTs, 2140
women, I2 = 0%, low quality evidence). There was no evidence of a difference between the
groups for the other primary outcomes.
LH versus VH (16 RCTs, 1440 women)
There was no evidence of a difference between the groups for any primary outcomes.
Robotic‐assisted hysterectomy (RH) versus LH (two RCTs, 152 women)
There was no evidence of a difference between the groups for any primary outcomes. Neither
of the studies reported satisfaction rates or quality of life.
Overall, the number of adverse events was low in the included studies.

Authors' conclusions

Among women undergoing hysterectomy for benign disease, VH appears to be superior to

LH and AH, as it is associated with faster return to normal activities. When technically
feasible, VH should be performed in preference to AH because of more rapid recovery and
fewer febrile episodes postoperatively. Where VH is not possible, LH has some advantages
over AH (including more rapid recovery and fewer febrile episodes and wound or abdominal
wall infections), but these are offset by a longer operating time. No advantages of LH over
VH could be found; LH had a longer operation time, and total laparoscopic hysterectomy
(TLH) had more urinary tract injuries. Of the three subcategories of LH, there are more RCT
data for laparoscopic‐assisted vaginal hysterectomy and LH than for TLH. Single‐port
laparoscopic hysterectomy and RH should either be abandoned or further evaluated since
there is a lack of evidence of any benefit over conventional LH. Overall, the evidence in this
review has to be interpreted with caution as adverse event rates were low, resulting in low
power for these comparisons. The surgical approach to hysterectomy should be discussed and
decided in the light of the relative benefits and hazards. These benefits and hazards seem to
be dependent on surgical expertise and this may influence the decision. In conclusion, when
VH is not feasible, LH may avoid the need for AH, but LH is associated with more urinary
tract injuries. There is no evidence that RH is of benefit in this population. Preferably, the
surgical approach to hysterectomy should be decided by the woman in discussion with her
surgeon.

Summary of findings

Summary of findings for the main comparison. Vaginal hysterectomy versus abdominal
hysterectomy for benign gynaecological disease

Vaginal hysterectomy versus abdominal hysterectomy for benign gynaecological

disease
 Patient or population: patients with benign gynaecological disease
Settings: hospital
Intervention: vaginal versus abdominal hysterectomy

Outcom Illustrative comparative Relativ No of Quality of Commen

es risks* (95% CI) e effect participan the ts
(95% ts evidence
Assumed Correspondi CI) (studies) (GRADE)
risk ng risk

Abdominal Vaginal
hysterecto hysterectom
my y

Return The mean The mean — 176 ⊕⊕⊕⊝ —

to return to return to (3 studies) moderate
1
normal normal normal
activitie activities activities
s (days) (days) in the (days) in the
AH group VH group
was was
42.7 days 9.5 lower
(12.6 to 6.4
lower)

Urinary 0 per 1000 0 per 1000 OR 439 ⊕⊕⊕⊝ There

tract (0 to 0) 3.09 (4 studies) moderate were no
2,3
(bladder (0.48 urinary
or to tract
ureter) 19.97) injuries in
injury one study

*The basis for the assumed risk is the median control group risk across studies.
The corresponding risk (and its 95% confidence interval) is based on the assumed risk in
the comparison group and the relative effect of the intervention (and its 95% CI).
AH: abdominal hysterectomy; CI: confidence interval; OR: odds ratio; VH: vaginal
hysterectomy

GRADE Working Group grades of evidence

High quality: Further research is very unlikely to change our confidence in the estimate of
effect.
Moderate quality: Further research is likely to have an important impact on our
confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our
confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.
1
There was a large difference in return to normal activities between the different studies; the
analysis had high heterogeneity (I2 = 75%) but consistent direction of effect.
2
In 2 studies there was doubt about the method used for random sequence generation.
3
There were only three events altogether, all in the VH arms.
Summary of findings 2. Laparoscopic hysterectomy versus abdominal hysterectomy for
benign gynaecological disease

Laparoscopic hysterectomy versus abdominal hysterectomy for benign

gynaecological disease

Patient or population: patients with benign gynaecological disease

Settings: hospital
Intervention: laparoscopic versus abdominal hysterectomy

Outcom Illustrative comparative Relativ No of Quality Commen

es risks* (95% CI) e effect participan of the ts
(95% ts evidence
Assumed Correspondi CI) (studies) (GRAD
risk ng risk E)

Abdominal Laparoscopi
hysterecto c
my hysterectomy

Return The mean The mean — 520 ⊕⊕⊝ —

to return to return to (6 studies) ⊝
normal normal normal low1,2
activities activities activities
(days) (days) in the (days) in the
AH group LH group was
was 13.6 lower
36.3 days (15.4 to 11.8
lower)

Urinary 10 per 1000 24 per 1000 OR 2140 ⊕⊕⊝ —

tract (12 to 46) 2.44 (13 ⊝
(bladder (1.24 to studies) low1,3
or 4.80)
ureter)
injury

Bowel 7 per 1000 1 per 1000 OR 1175 ⊕⊕⊕ —

injury (0 to 11) 0.21 (4 studies) ⊝
(0.03 to moderat
1.33) e3

Vascula 9 per 1000 16 per 1000 OR 956 ⊕⊕⊕ —

r injury (5 to 51) 1.76 (2 studies) ⊝
(0.52 to moderat
5.87) e3
 Bleeding 16 per 1000 6 per 1000 OR 1266 ⊕⊕⊝ —
(2 to 19) 0.45 (5 studies) ⊝
(0.15 to low3,4
1.37)

*The basis for the assumed risk is the median control group risk across studies.
The corresponding risk (and its 95% confidence interval) is based on the assumed risk in
the comparison group and the relative effect of the intervention (and its 95% CI).
AH: abdominal hysterectomy; CI: confidence interval; LH: laparoscopic
hysterectomy; OR: odds ratio

GRADE Working Group grades of evidence

High quality: Further research is very unlikely to change our confidence in the estimate of
effect.
Moderate quality: Further research is likely to have an important impact on our
confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our
confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.
1
In some studies there was doubt about the method used for random sequence generation or
allocation of patients. Furthermore, one study did not perform an intention‐to‐treat analysis.
2
There was a large difference in return to normal activities between the different studies; the
analysis had moderate heterogeneity (I2 = 48%) but consistent direction of effect.
3
Wide confidence intervals crossing the line of no effect.
4
In some studies there was doubt about the method used for random sequence generation or
allocation of participants.
Summary of findings 3. Laparoscopic hysterectomy versus vaginal hysterectomy for benign
gynaecological disease

Laparoscopic hysterectomy versus vaginal hysterectomy for benign gynaecological

disease

Patient or population: patients with benign gynaecological disease

Settings: hospital
Intervention: laparoscopic versus vaginal hysterectomy

Outcomes Illustrative comparative Relativ No of Quality Commen

risks* (95% CI) e effect participan of the ts
(95% ts evidence
Assumed Correspondi CI) (studies) (GRAD
risk ng risk E)

Vaginal Laparoscopi
hysterecto c
my hysterectom
y

Return to The mean The mean — 140 ⊕⊕⊕ —

normal return to return to (2 studies) ⊝
 activities normal normal moderat
(days) activities activities e1
(days) in the (days) in the
VH group LH group
was was
25.2 days 1.1 lower
(4.2 lower to
2.1 higher)

Urinary 16 per 1000 16 per 1000 OR 865 ⊕⊕⊝ —

tract (6 to 42) 1.0 (7 studies) ⊝
(bladder (0.36 low2,3
or ureter) to
injury 2.75)

Vascular 12 per 1000 18 per 1000 OR 745 ⊕⊕⊝ —

injury (6 to 58) 1.58 (5 studies) ⊝
(0.48 low3,4
to
5.27)

Bleeding 29 per 1000 25 per 1000 OR 644 ⊕⊕⊝ —

(9 to 70) 2.45 (3 studies) ⊝
(0.38 low3,5
to
15.78)

Unintend 24 per 1000 37 per 1000 OR 1160 ⊕⊕⊝ —

ed (19 to 73) 1.55 (10 ⊝
laparoto (0.76 studies) low2,3
my to
3.15)

*The basis for the assumed risk is the median control group risk across studies.
The corresponding risk (and its 95% confidence interval) is based on the assumed risk in
the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; LH: laparoscopic hysterectomy; OR: odds ratio; VH: vaginal
hysterectomy

GRADE Working Group grades of evidence

High quality: Further research is very unlikely to change our confidence in the estimate of
effect.
Moderate quality: Further research is likely to have an important impact on our
confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our
confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.
1
Wide confidence intervals crossing the line of no effect.
2
In some studies there was doubt about the method used for random sequence generation or
allocation of patients.
3
Wide confidence intervals crossing the line of no effect.
4
In one study it was unclear how participants were allocated to their study group.
5
In two studies it was unclear how participants were randomised and allocated.

Quality of the evidence

The quality of the evidence for the comparisons included in this review is mainly graded as
low or moderate, resulting in uncertainty regarding the effects on primary and secondary
outcomes between the different approaches to hysterectomy (summary of findings Table for
the main comparison; summary of findings Table 2; summary of findings Table 3).
Limitations in the evidence included imprecision of results and inadequate reporting of study
methods (e.g. randomisation and allocation procedure, no predefined primary and secondary
outcomes). The 'Summary of findings' tables show the quality of evidence for our primary
outcomes for the three main comparisons. With regard to abdominal versus vaginal
hysterectomy there was a large difference in return to normal activities between the different
studies, although all results were in favour of vaginal hysterectomy. In two studies, studying
urinary tract injury, there was doubt about the method used for random sequence generation.
With regard to laparoscopic versus abdominal hysterectomy doubt existed about the method
used for random sequence generation or allocation of patients. There was a large difference in
return to normal activities between the different studies, although all results were in favour of
laparoscopic hysterectomy. Furthermore, there were wide confidence intervals crossing the
line of no effect present.
Also, with regard to the comparison between laparoscopic and vaginal hysterectomy wide
confidence intervals crossing the line of no effect were present. In some studies, studying
urinary tract injury and unintended laparotomy, there was doubt about the method used for
random sequence generation or allocation of patients. In some trials, studying complications,
it was unclear how participants were randomised and allocated to their study group.
The majority of trials had unblinded participants, mostly imputed to the nature of the
intervention (e.g. vaginal hysterectomy resulting in no abdominal scar in contrast with
abdominal hysterectomy). However, as for example Miskry 2003 and Paraiso 2013showed,
sham abdominal dressings could be applied to blinded participants. This is particularly
beneficial for unbiased patient‐reported outcomes, such as postoperative pain, satisfaction or
quality of life. Trials studying short‐term outcomes in short follow‐up periods, had minimal
missing data. However, importantly, some of the trials evaluating long‐term outcomes, such
as quality of life (e.g. Garry 2004), had significant numbers lost to follow‐up. Therefore, the
outcomes of these studies have to be interpreted with caution. An important reason for the
low quality of evidence was imprecision of results, particularly resulting from the low
number of adverse events in terms of intraoperative and major long‐term complications per
study. This is important to take into account when interpreting the results regarding the safety
of each type of hysterectomy.
Most outcomes for the comparisons between laparoscopic and abdominal hysterectomy, as
well as laparoscopic and vaginal hysterectomy, are based on the large trial by Garry 2004,
with a moderate risk of bias and most importantly a high rate of incomplete outcome
data. Garry 2004 performed the largest trial (n = 1380) and used major complications as the
primary outcome. The recruitment target was met in the laparoscopic versus abdominal
hysterectomy arm but not in the laparoscopic versus vaginal hysterectomy arm. With regard
to the comparison between vaginal and abdominal hysterectomy, the conclusions are based
on six trials with comparable sample sizes and low risk of bias. The sensitivity analysis has
led to some changes in statistical significance in various variables on bleeding and blood loss.
Complication rates, operation times and recovery times did not change with the exclusion of
trials with more detrimental trial quality.
In conclusion, further research is at least likely to have an important impact on our
confidence in the estimate of effect and is likely to change the estimate.

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